Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00931385
First received: July 1, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BI 1744
Drug: bi1744
Drug: Placebo
Drug: Foradil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment [ Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  • FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.


Secondary Outcome Measures:
  • Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment. ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.

  • Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.

  • Peak FEV1 (0-3h) Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.

  • Trough FEV1 Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.

  • Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response [ Time Frame: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response [ Time Frame: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment. ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • Peak FVC (0-3h) Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.

  • Trough FVC Response [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).


Enrollment: 99
Study Start Date: June 2009
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1744 (Olodaterol) Low Dose
BI1744 Low Dose once daily
Drug: bi1744
1744 low dose
Experimental: BI 1744 (Olodaterol) Med Dose
BI 1744 Med Dose once daily
Drug: BI 1744
BI1744 Respimat Med Dose Once Daily
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo Respimat and Foradil Placebo
Active Comparator: Foradil
Foradil 12 mcg twice daily
Drug: Foradil
Foradil 12 mcg twice daily and Placebo Respimat

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients willing to participate with confirmed diagnosis of COPD
  • 40 years of age or older
  • having a 10 pack year smoking history
  • able to perform serial pulmonary function tests
  • able to use both a DPI and Respimat device

Exclusion Criteria:

  • Significant other disease
  • clinically relevant abnormal hematology, chemistry, or urinalysis
  • history of asthma
  • diagnosis of thyrotoxicosis
  • paroxysmal tachycardia related to beta agonists
  • history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
  • active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
  • significant alcohol or drug use
  • pulmonary resection
  • taking oral beta adrenergics
  • taking unstable oral steroids
  • daytime oxygen
  • enrolled in rehabilitation program
  • enrolled in another study or taking investigational products
  • pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
  • those who are not willing to comply with pulmonary medication washouts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931385

Locations
United States, Florida
1222.24.24011 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Kansas
1222.24.24009 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
United States, Louisiana
1222.24.24007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
United States, Ohio
1222.24.24002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
1222.24.24010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, South Carolina
1222.24.24004 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1222.24.24006 Boehringer Ingelheim Investigational Site
Gaffney, South Carolina, United States
1222.24.24005 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1222.24.24008 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1222.24.24001 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1222.24.24003 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00931385     History of Changes
Other Study ID Numbers: 1222.24
Study First Received: July 1, 2009
Results First Received: March 28, 2014
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014